# K202862: Gx-IVF, Gx-TL, Gx-MOPS PLUS

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: May 14, 2021 after 228 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K034063 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081116: G-Ivf G5 Series, Vitrolife Sweden AB (2008) Summary page 4.
- K133568: G-TL, Vitrolife, Inc. (2014) Summary page 4.
- K081115: G-Mops G5 Series, Vitrolife Sweden AB (2008) Summary page 4.

## Indications for use
Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination. Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer. Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.

Source page: https://510kreport.com/device/K202862
Methodology: https://510kreport.com/methodology